DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
Regarding the previous drawing objection in light of claim 19, the annotated figure provided in applicants remarks is sufficient to overcome the drawing objection. It appears the claimed “laterally inner and upper edge of the first flange” of claim 16 is referred to as one of the two edges described in claim 19 as illustrated in applicants annotated figure. Therefore, the claim will be interpreted as two edges, wherein one of the two edges is the laterally inner and upper edge of claim 16.
Response to Arguments
Applicant’s arguments, see pages 2-4, filed 08/25/2025, with respect to the 102 rejection(s) of claim(s) 1 and 16 under Fowler have been fully considered and are persuasive. The examiner agrees that Fowler fails to disclose or suggest “a first profiled surface located on a laterally outer side of the first flange” as required by claim 1 and “a first track, the drive pin extending at least partially into the first track; and a first profiled surface that is planar and extends distally beyond the first track” as required by claim 16. The examiner also agrees that Fowler fails to disclose “a first profiled edge extending from a laterally outer surface of the first flange to a laterally inner upper edge of the first flange to extend across a majority of a lateral dimension of the first flange, such that the laterally outer surface is shorter than a laterally inner surface”. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Michelini et al. (US 20160278801) (claims 1 and 16) and Michelini et al. (US 20160278801) in view of Allen et al. (US 20130296848) (claim 10).
Claim Objections
Claims 3, 8-9, 11, 15, 17 and 19 are objected to because of the following informalities:
Claim 3, line 2: “the jaws” should recite “the first and second jaws”.
Claim 3, line 3: “the proximal portions” should recite “the proximal portions of the first and section flanges”.
Claim 8 (line 1) and claim 9 (line 2): “the profiled surface” should recite “the first profiled surface”.
Claim 11, line 4: “an outer surface” should recite “the outer surface”.
Claim 15, line 3: “the respective tracks” should recite “the respective first tracks of the first flange and the second flange”.
Claim 17, line 7: “an outer surface” should recite “the outer surface”.
Claim 19, line 3: “the outer surface” should recite “an outer surface”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 7-9, 16, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Michelini et al. (US 20160278801) [hereinafter Michelini].
The examiner notes that the embodiment of Figs. 17-26 is relied upon for the rejection. However, other embodiments will be relied upon for shared features not described in the embodiment of Figs. 17-26 (para. 0075).
Regarding claim 1, Michelini discloses a forceps 200 (Figs. 17-26, para. 0069) comprising:
a drive pin 224 (Figs. 17-18, para. 0069);
an outer tube 12 extending along a longitudinal axis (Fig. 2, para. 0055);
a first jaw 222 pivotably connected to the outer tube 12 (see Figs. 17-18, para. 0054), the first jaw 222 including a first flange located at a proximal portion of the first jaw 222 (see annotated Fig. 18 below, para. 0069-0070), the first flange including a first profiled surface located on a laterally outer side of the first flange (see annotated Fig. 23 below, para. 0069, 0073), the first profiled surface extending at a nonzero angle from a laterally outer surface of the first flange to a laterally inner upper edge of the first flange to extend across a majority of a lateral dimension of the first flange (see annotated Fig. 23 below), the first profiled surface configured to limit extension of the first flange laterally beyond an outer surface of the outer tube when the first jaw is in a closed position (Fig. 21, para. 0073; see note below regarding “configured to” language), wherein the first profiled surface is flat (see Figs. 19 and 23 which illustrate the first profiled surface having a smooth, even surface without bumps or indentations and is therefore defined as flat, para. 0073);
a second jaw 220 connected to the outer tube 12 (see Figs. 17-18, para. 0054); and
an inner shaft 38 located within the outer tube and extending along the longitudinal axis (Fig. 2, para. 0055), the inner shaft 38 connected to the first flange, via the drive pin 224 (para. 0055, 0061 0069; The examiner notes that the drive pin pivotably connects the first flange to control wires 216, 218 which connects the link 38. The claim does not require a direct connection between the drive pin and the inner shaft.), the inner shaft 38 translatable along the outer tube 12 to drive the drive pin 224 and the first flange to move the first jaw 222 between an open position and the closed position (Figs. 17-20, para. 0055, 0061, 0069-0070).
Note: “the first profiled surface configured to limit extension of the first flange laterally beyond an outer surface of the outer tube when the first jaw is in a closed position” is interpreted as functional language. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. As claimed, Michelini discloses all of the structure provided in the limitation to necessitate the functional language i.e. the first profiled surface (see annotated Fig. 23 below). Furthermore, Michelini discloses that the jaws are designed to form a smooth, atraumatic distal tip in the closed position (Figs. 19-21, para. 0073) and are shaped along its length “to prohibit soft tissue injury during insertion and removal of the grasping device from the patient” (para. 0073). Therefore, the first profiled surface of Michelini is capable of limiting the extension of the first flange laterally beyond the outer surface of the outer tube when the first jaw is in the closed position. The examiner further notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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Annotated Fig. 18 of Michelini
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Annotated Fig. 23 of Michelini
Regarding claim 7, Michelini discloses wherein the second jaw 220 is pivotably connected to the outer tube 12 (see Figs. 17-18, para. 0054).
Regarding claim 8, Michelini discloses wherein the profiled surface is a bevel (see annotated Fig. 23 above and annotated Figs. 21 and 23[b] below which illustrate the first profiled surface having a slanted/inclined surface).
Regarding claim 9, Michelini discloses wherein the first profiled surface is angled radially inward as the profiled surface (interpreted as the first profiled surface) extends from an axially distal location to an axially proximal location (see annotated Fig. 23 [a] below).
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Annotated Fig. 23 [a] of Michelini
Regarding claim 16, Michelini discloses a medical device 200 (Figs. 17-26, para. 0069) comprising:
a drive pin 224 (Figs. 17-18, para. 0069);
an outer tube 12 extending along a longitudinal axis (Fig. 2, para. 0055);
a first jaw 222 pivotably connected to the outer tube 12 (see Figs. 17-18, para. 0054), the first jaw 222 including a first flange located at a proximal portion of the first jaw 222 (see annotated Fig. 18 below, para. 0069-0070), the first flange including:
a first track 250c (Fig. 24, para. 0061), the drive pin 28 extending at least partially into the first track 250c (Fig. 18, para. 0054, 0061); and
a first profiled surface that is planar (see Figs. 21 and 23 [a] below; The examiner notes that planar is defined as “of, relating to, or lying in a plane. Annotated Figs. 21 and 23 [b] of Michelini below illustrates the first profiled surface lying or relating to a plane defined by the distal end of the jaw. Therefore, the first profiled surface meets the claim limitation.) and extends distally beyond the first track 250c (Figs. 23-24, para. 0054, 0061), and wherein the first profiled surface extends at an angle from a laterally outer surface of the first flange across a lateral midline of the first flange to a laterally inner and upper edge of the first flange (see annotated Fig. 23 above);
a second jaw 220 connected to the outer tube 12 (see Figs. 17-18, para. 0054); and
an inner shaft 38 located within the outer tube and extending along the longitudinal axis (Fig. 2, para. 0055), the inner shaft 38 connected to the first flange, via the drive pin 224 (para. 0055, 0061 0069; The examiner notes that the drive pin pivotably connects the first flange to control wires 216, 218 which connects the link 38. The claim does not require a direct connection between the drive pin and the inner shaft.), the inner shaft 38 translatable along the outer tube 12 to drive the drive pin 224 and the first flange to move the first jaw 222 between an open position and the closed position (Figs. 17-20, para. 0055, 0061, 0069-0070).
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Annotated Fig. 21 of Michelini Annotated Fig. 23 [b] of Michelini
Regarding claim 19, modified Michelini discloses wherein the first profiled surface defines two edges extending substantially axially along the first flange when the first jaw is in the closed position (see annotated Fig. 19 below, para. 0071, 0073 of Michelini), the two edges located radially inward of the outer surface of the outer tube when the first jaw is in the closed position (see annotated Fig. 19 below, annotated Fig. 23 above which illustrates the first profiled surface extending from the laterally outer surface to the laterally inner, upper, edge; Therefore, the first profiled surface extends radially inward relative to the outer surface of the outer tube in the closed position, and Fig. 21, para. 0071, 0073 of Michelini).
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Annotated Fig. 19 of Michelini
Regarding claim 20, Michelini discloses wherein the first profiled surface is angled radially inward as the profiled surface (interpreted as the first profiled surface) extends from an axially distal location to an axially proximal location (see annotated Fig. 23 [a] above).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Michelini et al. (US 20160278801), as applied to claims 1 and 16 above, and further in view of Allen et al. (US 20130296848) [hereinafter Allen].
Regarding claims 2 and 17, Michelini discloses all of the limitations set forth above in claims 1 and 16. Regarding claim 17, Michelini further discloses the first profiled surface configured to limit extension of the first flange laterally beyond an outer surface of the outer tube when the first jaw is in a closed position (see note above in the rejection of claim 1; The examiner notes that the first profiled surface of Michelini in the rejection of claim 16 includes all of the structure required to necessitate the functional language of claim 17).
However, Michelini fails to disclose wherein the first jaw includes a second flange located at the proximal portion of the first jaw, the second flange including a second profiled surface configured to limit extension of the second flange laterally beyond the outer surface of the outer tube when the first jaw is in the closed position (claim 2) and wherein the first jaw includes a second flange located at the proximal portion of the first jaw, the second flange including a second profiled surface extending at an angle from a laterally outer surface of the second flange to an upper edge of the second flange, the second profiled surface configured to limit extension of the second flange laterally beyond an outer surface of the outer tube when the first jaw is in the closed position (claim 17).
Allen in the same field of endeavor teaches forceps 10 (Fig. 1) comprising double flanged jaws (30, 32) (Fig. 3, para. 0050), wherein a first jaw 30 includes first and second flanges (30a, 30b) located at a proximal portion of the first jaw (Figs. 3, 10, para. 0058) and a second jaw 32 includes third and fourth flanges (32a, 32b) arranged in a nested configuration and located at a proximal portion of the second jaw (Figs. 3, 10, para. 0058, 0078).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second jaws having single flanges in Michelini to include the double/dual flanges; wherein the flanges of the second jaw are arranged in the nested configuration with respect to the first jaw, as taught by Allen, since Allen teaches that providing the jaws with the double flange configuration would allow additional constraints between the two jaws such that lateral movement between the sets of flanges is reduced (see Fig. 14, para. 0082 of Allen). The modification would achieve the predicable result of allowing the flanges of the first jaw to suitably nest with the flanges of the second jaw such that the ability to simultaneously actuate the jaws relative to one another is maintained (see Figs. 10, 14, para. 0069, 0082 of Allen).
The combination of Michelini in view of Allen would result in a product wherein the second flange includes a second profiled surface identical to the first profiled surface defined in claims 1 and 16 as disclosed in Michelini (see the rejection claims 1 and 16 above) since the modification is a duplication of the single flange (Allen teaches two flanged jaws, as opposed to one, para. 0050, 0058, 0078 of Allen) such that the first jaw of Michelini comprise the first and second flanges. Since the second flange would have the same structure as the first flange, the second flange would include a second profiled surface extending at an angle from a laterally outer surface of the second flange to an upper edge of the second flange (see annotated Fig. 23 of Michelini above) and also be configured to limit extension of the second flange laterally beyond the outer surface of the outer tube when the first jaw is in the closed position (see note above in claim 1 which discusses the interpretation of “configured to” and functional language).
Regarding claim 18, modified Michelini discloses wherein the second flange includes a second track 250c receiving the drive pin 224 at least partially therein (Fig. 17-18, 24, para. 0054, 0061 of Michelini; see rejection of claim 17 above which duplicates the first flange of the first jaw).
Claim(s) 10-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Michelini et al. (US 20160278801) in view of Allen et al. (US 20130296848) [hereinafter Allen].
The examiner notes that the embodiment of Figs. 17-26 is relied upon for the rejection. However, other embodiments will be relied upon for shared features not described in the embodiment of Figs. 17-26 (para. 0075).
Regarding claim 10, Michelini discloses a forceps a forceps 200 (Figs. 17-26, para. 0069) comprising:
a drive pin 224 (Figs. 17-18, para. 0069);
an outer tube 12 extending along a longitudinal axis (Fig. 2, para. 0055);
a first jaw 222 connected to the outer tube 12 (see Figs. 17-18, para. 0054), the first jaw 222 including a first flange located at a proximal portion of the first jaw 222 (see annotated Fig. 18 above, para. 0069-0070), the first flange including a first profiled edge extending from a laterally outer surface of the first flange to a laterally inner upper edge of the first flange to extend across a majority of a lateral dimension of the first flange (see annotated Fig. 23 above, para. 0069, 0073), such that the laterally outer surface is shorter than a laterally inner surface (due to the non-zero angle of the first profiled edge, see annotate Figs. 23 [c] and 22 below), the first profiled edge configured to limit extension of the first flange laterally beyond an outer surface of the outer tube (see note above in regards to “configured to” language), wherein the first profiled edge is flat (see Figs. 19 and 23 which illustrate the first profiled surface having a smooth, even surface without bumps or indentations and is therefore defined as flat, para. 0073);
a second jaw 220 pivotably connected to the outer tube 12 (see Figs. 17-18, para. 0054); and
an inner shaft 38 located within the outer tube and extending along the longitudinal axis (Fig. 2, para. 0055), the inner shaft 38 connected to the first flange, via the drive pin 224 (para. 0055, 0061 0069; The examiner notes that the drive pin pivotably connects the first flange to control wires 216, 218 which connects the link 38. The claim does not require a direct connection between the drive pin and the inner shaft.), the inner shaft 38 translatable along the outer tube 12 to drive the drive pin 224 and the first flange to move the first jaw 222 and the second jaw 220 between open and closed positions (Figs. 17-20, para. 0055, 0061, 0069-0070).
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Annotated Fig. 23 [c] of Michelini Annotated Fig. 22 of Michelini
However, Michelini fails to disclose the first jaw including a second flange.
Allen in the same field of endeavor teaches forceps 10 (Fig. 1) comprising double flanged jaws (30, 32) (Fig. 3, para. 0050), wherein a first jaw 30 includes first and second flanges (30a, 30b) located at a proximal portion of the first jaw (Figs. 3, 10, para. 0058) and a second jaw 32 includes third and fourth flanges (32a, 32b) arranged in a nested configuration and located at a proximal portion of the second jaw (Figs. 3, 10, para. 0058, 0078).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second jaws having single flanges in Michelini to include the double/dual flanges; wherein the flanges of the second jaw are arranged in the nested configuration with respect to the first jaw, as taught by Allen, since Allen teaches that providing the jaws with the double flange configuration would allow additional constraints between the two jaws such that lateral movement between the sets of flanges is reduced (see Fig. 14, para. 0082 of Allen). The modification would achieve the predicable result of allowing the flanges of the first jaw to suitably nest with the flanges of the second jaw such that the ability to simultaneously actuate the jaws relative to one another is maintained (see Figs. 10, 14, para. 0069, 0082 of Allen).
Regarding claim 11, modified Michelini discloses wherein the first jaw 222 of Michelini (para. 0069-0070 of Michelini) includes a second flange 32b located at the proximal portion of the first jaw as taught by Allen (Figs. 3, 10, para. 0058 of Allen), the second flange including a second profiled edge (see annotated Fig. 23 [c] of Michelini above; The examiner notes that the second profiled edge would be identical to the first profiled edge, see rejection of claim 10 above) configured to limit extension of the second flange laterally beyond the outer surface of the outer tube when the first jaw is in the closed position (see note above in the rejection of claim 1 regarding “configured to” language).
Regarding claim 12, modified Michelini discloses wherein the second jaw 220 (Figs. 17-18, para. 0069 of Michelini) includes a third flange and a fourth flange, each located at a proximal portion of the second jaw (see rejection of claim 10 above which modified the single flange of the second jaw 220 to have dual flanges each located at the proximal portion of the second jaw (Figs. 3, 10, para. 0058, 0078) as taught by Allen)
Regarding claim 13, modified Michelini discloses wherein each of the first flange and the second flange include a first track 250c receiving the drive pin 224 at least partially therein (Fig. 17-18, 24, para. 0054, 0061 of Michelini).
Regarding claim 15, modified Michelini discloses wherein the first profiled edge is located with respect to the first track 250c of the first flange to extend a thickness of the first flange adjacent a distal termination of the respective tracks (interpreted as the first tracks of the first and second flanges) (see note below) [Note: Under broadest reasonable interpretation, “adjacent” is defined as “not distant” or “nearby” (see attached Merriam-Webster Dictionary definition). Michelini illustrates the first profiled edge extending along the majority of the length of the first flange such that the distal termination of the first tracks 250c is adjacent or “nearby” the first profiled edge (Figs. 23-24, para. 0059, 0073; see annotated Fig. 23 [c] of Michelini above).
Claim(s) 3-6, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Michelini et al. (US 20160278801) in view of Allen et al. (US 20130296848), as applied to claims 2 and 13 above, and in further view of Williams et al. (US 20190015124) [hereinafter Williams].
Regarding claim 3, modified Michelini discloses all of the limitations set forth above in claim 2. Modified Michelini further discloses wherein the first flange and the second flange each include a proximal portion extending laterally outward of the outer tube when the jaws are in the open position (Figs. 17-18, para. 0069 of Michelini; Figs. 2A, 6, para. 0055, 0073-0074 of Allen), the proximal portions having a triangular profile (Figs. 17-18, para. 0069 of Michelini), the first profiled surface and the second profiled surface intersecting the triangular profile (see annotated Fig. 23 of Michelini above which illustrates the first profiled surface curving into the triangular profile of the flange, that curve defining the non-zero angle).
However, modified Michelini fails to disclose the proximal portions having an oval profile.
Williams in the same field of endeavor teaches a forceps comprising a first flange 32 and a second flange 34, each flange including a proximal portion extending laterally outward of an outer tube 54 when jaws 20, 22 are in an open position (Fig. 2), the proximal portions having an oval profile (best shown in Fig. 3 of Williams, para. 0013) as a known flange shape in the art.
It would have been an obvious matter of design choice to modify the shape of the profiles of the first flange and the second flange of Michelini to include the oval shape as taught by Williams, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 4, modified Michelini discloses wherein the second jaw 220 (Figs. 17-18, para. 0069 of Michelini) includes a third flange and a fourth flange, each located at a proximal portion of the second jaw (see rejection of claim 2 above which modified the single flange of the second jaw 220 to have dual flanges each located at the proximal portion of the second jaw (Figs. 3, 10, para. 0058, 0078) as taught by Allen).
Regarding claim 5, modified Michelini discloses wherein the first flange and the second flange 32a, 32b are positioned laterally outward of the third flange and the fourth flange 30a, 30b (Figs. 10, 14 of Allen).
Regarding claim 6, modified Michelini discloses wherein the third flange and the fourth flange include a third profiled surface and a fourth profiled surface, respectfully, configured to limit extension of the third flange and the fourth flange, respectively, laterally beyond the outer surface of the outer tube. (Note: The combination of Michelini in view of Allen and Williams would result in a product wherein the third and fourth flanges include a third and fourth profiled surface, respectively, identical to the first profiled surface defined above in the rejection of claim 1 (see annotated Fig. 23 of Michelini above) since the modification is a duplication of the single flange of Michelini such that the second jaw of Michelini comprise the third and fourth flanges. Since the third and fourth flanges would have the same structure as the first flange, the third and fourth flanges would also be configured to limit extension of the third and fourth flanges laterally beyond the outer surface of the outer tube (see note above in claim 1 which discusses the interpretation of “configured to” and functional language).
Regarding claim 14, modified Michelini discloses all of the limitations set forth above in claim 13. Modified Michelini further discloses wherein the inner shaft 38 comprises a pair of arms 214, 216 extending from a distal portion of the inner shaft (Figs. 17-18, para. 0054-0055), and the inner shaft 38 is translatable with respect to the outer tube 12 to drive the drive pin 224 to move the second jaw between the open and closed positions (Fig. 17-18, 24, para. 0054, 0061 of Michelini).
However, modified Michelini fails to disclose the drive pin being securable directly to the pair of arms.
Williams in the same field of endeavor teaches a forceps comprising a first flange 32 and a second flange 34 comprising a first track 40, 42 receiving a drive pin 62 at least partially therein (Fig. 3, para. 0013 of Williams), wherein an inner shaft 56 comprises a pair of arms 60 extending from a distal portion of the inner shaft (Fig. 3, para. 0013 of Williams), the drive pin 62 securable directly to the pair of arms (Fig. 3, para. 0013 of Williams), and the inner shaft 56 translatable with respect to the outer tube 54 to drive the drive pin 62 to move the second jaw between open and closed positions (para. 0013 of Williams).
The substitution of one known jaw drive mechanism ( translatable inner shaft comprising pair of arms as shown in Williams) for another (translatable inner link comprising a pair of control wires as shown in modified Michelini) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the inner shaft comprising pair of arms as shown in Williams would have yielded predictable results, namely, an alternative way to actuate the jaws between the open and closed positions (Fig. 3, para. 0013 of Williams) and support the dual flanges of the jaws during pivotable movements of the jaws (para. 0013 of Williams).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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